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MIAMI, Feb. 27, 2019 (GLOBE NEWSWIRE) -- OPKO Health, Inc. (NASDAQ: OPK) reports business highlights and financial results for the three months ended December 31, 2018.
CONFERENCE CALL & WEBCAST INFORMATION
OPKO’s senior management will provide a business update and discuss results in greater detail in a conference call and live audio webcast at 4:30 p.m. Eastern time today. The conference call dial-in and webcast information is as follows:
DOMESTIC DIAL-IN: 866-634-2258
INTERNATIONAL DIAL-IN: 330-863-3454
For those unable to participate in the live conference call or webcast, a replay will be available beginning approximately two hours after the close of the conference call. To access the replay, dial 855-859-2056 or 404-537-3406. The replay passcode is 4254518. The replay can be accessed for a period of time on OPKO’s website at http://investor.opko.com/events.cfm.
About OPKO Health, Inc.
OPKO Health is a diversified healthcare company. In diagnostics, its BioReference Laboratories is the nation's third largest clinical laboratory; GeneDx is a rapidly growing genetic testing business; the 4Kscore® prostate cancer test is used to confirm an elevated PSA to help decide about next steps such as prostate biopsy; Claros® 1 is a point-of-care diagnostics platform with a total PSA test approved by the FDA and testosterone as the most advanced test in development. In our pharmaceutical pipeline, RAYALDEE is our first pharmaceutical product to be marketed. OPK88003, a once-weekly oxyntomodulin for type 2 diabetes and obesity in Phase 2 clinical trials, is among a new class of GLP-1/glucagon receptor dual agonists. OPK88004, a SARM (selective androgen receptor modulator) has been studied for benign prostatic hyperplasia but we are exploring other potential indications. The Company’s most advanced product utilizing its CTP technology, a once-weekly human growth hormone for injection, is in Phase 3 trials, and is partnered with Pfizer. OPKO also has research, development, production and distribution facilities abroad. More information is available at www.opko.com.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains "forward-looking statements," as that term is defined under the Private Securities Litigation Reform Act of 1995 (PSLRA), which statements may be identified by words such as "expects," "plans," "projects," "will," "may," "anticipates," "believes," "should," "intends," "estimates," and other words of similar meaning, including statements regarding expected financial performance and expectations regarding the market for and sales of our products, our product development efforts and the expected benefits of our products, including whether our ongoing and future clinical trials will be successfully enrolled or completed on a timely basis or at all and whether the data from any of our trials will support submission or approval, validation and/or reimbursement for our products, whether we will be able to reverse or rescind the Novitas non coverage decision for the 4kscore test for Medicare beneficiaries, statements regarding our planned submission for FDA approval of the 4kscore test and the timeline for the submission, whether we will be able to develop OPK88004 for additional indications, whether OP88003 will be shown to be safe and effective and achieve even greater weight loss, the expected timing for launch of our products in development, the expected timing of commencing and concluding our clinical trials, expected enrollment in clinical trials, the timing of our regulatory submissions, our ability to market and sell any of our products in development, and expectations about developing RAYALDEE for dialysis patients, our ability to increase our commercial reach through expansion our RAYALDEE commercial sales force, our ability to expand the testing menu for the Claros® system and plans for scale up of our manufacturing capacity, as well as other non-historical statements about our expectations, beliefs or intentions regarding our business, technologies and products, financial condition, strategies or prospects. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements. These factors include those described in our Annual Reports on Form 10-K filed and to be filed with the Securities and Exchange Commission and in our other filings with the Securities and Exchange Commission, as well as the continuation and success of our relationship with Pfizer and our other partners, integration challenges for BioReference, and other acquired businesses, liquidity issues and the risks inherent in funding, developing and obtaining regulatory approvals of new, commercially-viable and competitive products and treatments, that earlier clinical results of effectiveness and safety may not be reproducible or indicative of future results, that the 4Kscore, RAYALDEE, hGH-CTP, OPK88003, OPK88004, and/or any of our compounds or diagnostic products under development may fail, may not achieve the expected results or effectiveness and may not generate data that would support the approval or marketing of products for the indications being studied or for other indications, that currently available over-the-counter and prescription products, as well as products under development by others, may prove to be as or more effective than our products for the indications being studied. In addition, forward-looking statements may also be adversely affected by general market factors, competitive product development, product availability, federal and state regulations and legislation, the regulatory process for new products and indications, manufacturing issues that may arise, patent positions and litigation, among other factors. The forward-looking statements contained in this press release speak only as of the date the statements were made, and we do not undertake any obligation to update forward-looking statements. We intend that all forward-looking statements be subject to the safe-harbor provisions of the PSLRA.
—Tables to Follow—
| OPKO Health, Inc. and Subsidiaries
Condensed Consolidated Balance Sheets
|Cash, cash equivalents and marketable securities||$||96.5||$||91.5|
|Other current assets||221.2||257.4|
|Total Current Assets||317.7||348.9|
|In-process Research and Development and Goodwill||1,335.8||1,364.4|
|Liabilities and Equity:|
|2033 Senior Notes, net of discount||31.6||29.2|
|Deferred tax liabilities||115.2||148.7|
|Other long-term liabilities, principally deferred revenue, contingent consideration and lines of credit||256.2||256.5|
|Total Liabilities and Equity||$||2,451.1||$||2,590.0|
|OPKO Health, Inc. and Subsidiaries
Condensed Consolidated Statements of Operations
(in millions, except share and per share data)
|For the three months ended
|For the twelve months ended
|Revenue from services||$||183.1||$||119.4||$||813.3||$||782.7|
|Revenue from products||25.4||33.8||107.1||107.8|
|Revenue from transfer of intellectual property||13.4||7.8||69.9||75.5|
|Costs and expenses|
|Cost of revenues||149.6||156.6||604.6||620.1|
|Selling, general and administrative||95.1||95.9||358.4||414.6|
|Research and development||33.3||34.2||125.6||126.4|
|Amortization of intangible assets||16.5||17.6||67.9||71.5|
|Asset impairment charges||21.8||13.2||21.8||13.2|
|Total Costs and expenses||311.9||318.6||1,161.5||1,242.4|
|Other income and (expense), net||(11.4||)||3.6||(6.0||)||4.5|
|Loss before income taxes and investment losses||(101.4||)||(154.0||)||(177.2||)||(271.9||)|
|Income tax benefit (provision)||28.3||(61.2||)||38.7||(18.9||)|
|Loss before investment losses||(73.1||)||(215.2||)||(138.5||)||(290.8||)|
|Loss from investments in investees||(3.0||)||(2.7||)||(14.5||)||(14.5||)|
|Loss per share, basic and diluted||$||(0.13||)||$||(0.39||)||$||(0.27||)||$||(0.55||)|